Bucherview Metrology Services Logo


A 2.5 Day Workshop
A Quality Calibration Program for
Biotech and Pharmaceutical Companies:
Meeting the FDA requirements
 for traceable calibration;
also included...
Paperless Records -
Designing and creating your
own electronic forms.

 

Course topics include:

 

Overview of the days agenda

The criticality of calibration

A short history of calibration

Background of FDA

Requirements

21 CFR Part 820.72 (FDA – QSR)

21 CFR Part 820.25 (Training requirements)

21 CFR Parts: 58, 110, 121, 145, 211, and 606

ISO 9000, ISO 13485

A Quality Calibration Program

Calibration procedures – writing them

Formatting

Generic vs. specific types of test instruments

Calibration procedures – using them

Document control

Updating and improving them

Training and availability

Validation vs. qualification

Calibration records

Specific requirements

The required items on a calibration form

Formatting

Filing, electronic and hard copy

How to make corrections to your records

Calibration labels

Calibration intervals

Calibration certificates

Traceability

4:1 – what it is and where it comes from

Uncertainty budgets

The correct way to state NIST traceability

Complying with environmental requirements

Out of tolerance procedures

What should be in place

Examples of forms

Procedures and examples

Solutions for handling missing test equipment

Managing a Quality Calibration Program

Setting up a new metrology department from scratch

Killing three birds with a single pass during your inventory data collection

Calibration Standards – getting the most bang for your buck

Implementing a new program

A lab liaison program

Training your customers (internal and external)

Managing a QCP through best practices/lessons learned

Scheduling and inventory control

Calibration management software – they are not all created equal

Continuous process improvements

Short cycling your test instrument’s due dates

Limited calibrations – the pros and cons

PMIs – extending the life of your test equipment

Calibration extension programs – the rare exception to the rule

The SI and the world of measurement

Calibrate Before Use vs. Standardize Before Use programs and labels

Comparing apples/oranges – full scale vs. % of Rdg

Getting the most out of your balances while meeting USP requirements

Accuracy vs. precision

In-house calibration vs. contract and third-party   calibration labs

Quality documents and procedures – when and how to use administrative procedures

Audit preparation and the paper trail

The responsibilities of a calibration department vs. those of the customer

Web sites and how they can be a great tool for your quality calibration program

Ethics

Safety

Resources

Paperless Records using MS Word

(Please bring a laptop w/MS Word 2003)

The difference between a form and a record

Formatting using MS Word

How to use Word and the Form tools

Making templates

Making pre-filled templates

Protecting your forms

Using your forms – cosigning and re-protection

Assist attendees with their individual requirements using MS Word

Hands on practice  and problem solving for those using MS Word for their eRecords

Paperless Records using Adobe Acrobat 8.0 Pro

(Please bring a laptop w/Adobe Acrobat 8.0 Pro installed

if you want help using it during the workshop)

Modifying your Word form to comply with Adobe Acrobat formatting

Changing your MS Word form into an Adobe Acrobat form

Using the various form tools in Adobe Acrobat

Setting up digital signatures

Lessons learned using Adobe Acrobat

Assist attendees with their individual requirements using Adobe Acrobat

Hands on practice and problem solving for those using Adobe Acrobat for their eRecords

 

If you have questions or need more information,
please send us an email at: yokota-69@charter.net


View My Stats